Indonesia: Regulating registration and imports of pharmaceutical products
The Ministry of Health has issued Decree No. 1010/08 regulating the registration and import of pharmaceutical products. The Decree establishes a separation between manufacturers and wholesalers to protect consumer health and the safety of pharmaceutical products. With regard to imports, initial registration must now be made through an Indonesian manufacturer. Once the registration process is completed a foreign company may directly sell to the wholesalers concerned.
Any Evidence-Based Deliberation:
|Is there anything in the public record to suggest that evidence of the effectiveness of the proposed measure was considered during official deliberations?||Don't know|
|Is there any evidence that alternatives to the proposed measure were considered?||Don't Know|
|Is there anything in the public record that suggests that empirical evidence informed the comparison across the alternatives available to government?||Don't Know|
|Was such evidence identified?||Don't Know|
|Is such evidence publicly available?||Don't Know|
|Did the official decision-maker in question provide an explanation as to why a chosen measure was favoured over alternatives?||Don't Know|
|Is there any evidence to suggest that potentially affected trading partners were consulted before the measures were taken?||Don't Know|
|Is there any evidence that safeguards have been put in place to ensure that implementation of the initiative is transparent and non-discriminatory?||Don't Know|
|Did the government state its intention to review the measure within one year of implementation?||Don't Know|
Date of inception: 3 Nov 2008
GTA Evaluation: Amber
Measure listed as verified, see Annex I, WTO monitoring report 26 March 2009.
Government Response: Decree of Minister of health number 1010/Menkes/Per/XI/2008 has been issued with the objective of consumer protection on health and safety grounds and to promote the overall quality of pharmaceutical products marketed in Indonesia. This regulation is not new but is based on Decree of the Minister of Health number 919/Menkes/Per/VI./2000. Under this decree, a distinction is made between pharmaceutical manufactures and wholesalers. Prior to this decree, wholesalers could register as well as distribute products. However taking into account rapid changes in technology as reflected in developing pharmaceutical product standards, the regulators have found that a large number of wholesalers did not have the required laboratory facilities to register these products and a growing number also showed a lack of awareness of standard procedures, such as the preparation of dossiers. In order to address these shortcomings, this Decree only allows the domestically based pharmaceutical manufacturers to register products, and only wholesalers are allowed to distribute the products in Indonesia. This distinction is considered to represent the least trade restrictive approach to achieve the legitimate goals set. Imports are not restricted and as with all countries, import of pharmaceutical products must be registered and now the initial registration must be made through an Indonesian based pharmaceutical manufacturer. Once the product is registered the foreign company may directly sell to wholesalers. Although article 10 (2) of this Decree requires overseas manufactures to transfer technology and manufacture within five years, this does not apply to products under patent protection, which constitutes the vast majority of imports of pharmaceutical products. For generic products, it is considered that local production is the best means to ensure the supply of affordable drugs for a developing nation.